Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Is there an annual inspection expectation for retention samples similar to the ones expected or required for drug products? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans We test water for endotoxins for a non-sterile API that is sold for further processing to produce a sterile product. Should we also test the API itself for endotoxins? 1.09K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there a chain of custody for reference standard materials? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans This is in regard to a slide 11-5 in laboratory operations, which said that you had to have a procedure for sampling. Was that referring to a sampling procedure for obtaining a bulk sample from the lot or was that referring to sampling that bulk sample for use in the laboratory? 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans If a process has several purification steps and the first step fails to meet specifications, but this can be corrected by adjustment in a subsequent step, is an OOS investigation needed for this first step? 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans Can new retest dates continue to be assigned if material remains? 934 viewsDrugsPharmaceutical 0 Votes 1 Ans Can the user assign retest dates later than manufacturer’s expiration date? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans Do we need to keep reserve samples of starting materials used in API manufacturing? Do they need to keep samples of intermediates if they’re not marketed? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans Is validation data required in support of blending? 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans A company wants to manufacture a blend of chemical actives, where no chemical synthesis extraction occurs. This blend is then sold for use in the manufacture of a consumer product. Is this blend considered an API or does API starting material manifest itself? 977 viewsDrugsPharmaceutical 0 Votes 1 Ans Could you elaborate on section 12.6? Would a change in the source of an API starting material require revalidation? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the quality section need to sign off / approve the validation reports in addition to validation protocols? 955 viewsDrugsPharmaceutical 0 Votes 1 Ans Does Q7A address process development reports? 1.02K viewsDrugsPharmaceutical 0 Votes 1 Ans Can you give examples of appropriate documentation or other alternate means to indicate the status of equipment? 806 viewsDrugsPharmaceutical 0 Votes 1 Ans What is the difference between “witness” and “verify” in Q7A? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Drug Product Manufacturers may produce placebo product during the PQ-phase to demonstrate the process and equipment are functioning prior to manufacturing commercial product. What is expected in performing a PQ in an API facility? 1.06K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the expectations for qualifying equipment? For instance, does the OQ need to go to the limit that the piece of equipment is capable of running, or can it just go to the typical operating conditions, i.e., temperature, pressure, etc.? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans We have generalized templates and from there we will take that and add the specific information for the equipment to those templates. We’re wondering if the original templates are signed off after the additional information has been added to the templates, do we need to have an additional review by quality prior to the execution of the IQ? 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans Can approval of the IQ/OQ protocols be delegated if the template document has been approved by quality? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Are charging operations, even of non-critical materials, considered as critical steps that must be documented and verified? 1.14K viewsDrugsPharmaceutical « Previous 1 2 … 50 51 52 53 54 … 82 83 Next » Question and answer is powered by anspress.net
